Production Facilities
Çerkezköy Plant
Çerkezköy Penicillin Group β- Lactam Products Manufacturing Plant was projected in 1996 by the American / Italian Foster Wheeler-Steril, a company with international experience in the pharmaceuticals industry
Manufacturing sites, infrastructural, storage and quality control systems are designed to international regulations.
The plant was built as an enclosed area of 7.200 m2 on a land of 22.000 m2 within Çerkezköy Organized Industrial Zone at about 100 km to Istanbul, and was opened and put into service in 1998.
The manufacturing areas are designed and built in line with the requirements of international cGMP (current Good Manufacturing Practices) so as to manufacture injectable and oral solid products in the most ergonomic manner and in accordance with the regulatory requirements.
Pharmaceuticals in the following forms are manufactured in this plant, and the annual manufacturing capacity at a single shift is as follows.
| Pharmaceutical Form | Annual Capacity * |
|---|---|
| Tablet | 180 million tablets |
| Film-Coated Tablet | 1.300 tons (coating capacity) |
| Capsule | 82 million capsules |
| Dry Powder Suspension | 10 million bottles |
| Injectable Sterile Powder | 20 million flacons |
| (*) On the basis of a single 8-hour shift a day. | |
The Quality Assurance System
Our approach is internalized and applied by all functions of the concern. For achieving the targeted product and production quality, building, equipment, cleaning, method and process validations have been completely performed since the very design stage of the facility up to date, and are monitored through the annual revalidation plans developed on the basis of annual reviews.
Our plant has been inspected by the Turkish Ministry of Health and many other foreign institutions and organizations, private and public, so far, and at every time confirmed to comply with international standards.
Some of the foreign institutions and our customers who have confirmed our compliance upon inspections include:
- German Ministry of Health
- Danish Administration of Drugs
- U.K. Consilient Health
- Irish Arrow Corporation
- Macedonian Administration of Drugs
- Malaysian Hovid Corporation
- Slovak Administration of Drugs
- Slovene Lek Corporation
- Umman Administration of Drugs
Our oral solid manufacturing site has been entitled to a certification of compliance with EU regulations upon an inspection by the German Ministry of Health.
In 2004, the certificates of
- ISO 9001 Quality Management System
- ISO 14001 Environment Management System and
- OHSAS 18001 Working Health and Safety Management System
provided the evidence that our plant complied with international quality systems in addition to cGMP regulations.
